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BioDelivery Sciences International completes acquisition of Elyxyb for acute migraine treatment in the U.S. and Canada

Written by | 26 Sep 2021

BioDelivery Sciences International, Inc. a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced that it has completed the acquisition of U.S. and Canadian rights… read more.

FDA approves Invega Hayfera (6-month paliperidone palmitate), first and only twice-yearly treatment for adults with schizophrenia – Janssen Pharmaceuticals

Written by | 24 Sep 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the FDA has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the… read more.

UK MHRA grants marketing authorisation for Cibinqo for adults and adolescents with moderate to severe atopic dermatitis – Pfizer

Written by | 22 Sep 2021

Pfizer Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1… read more.

DisCoVeRy trial of Verklury concluded there was no clinical benefit in hospitalised patients with COVID 19 – Gilead Sciences

Written by | 21 Sep 2021

A study conducted in Europe of Gilead’s Verklury (remdesivir) concluded that the antiviral provided no clinical benefit in hospitalized patients with COVID-19 compared to existing treatments . The… read more.

Moderna highlights new clinical data on SpikeVax, its COVID-19 vaccine

Written by | 20 Sep 2021

Moderna, Inc. highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern , including in a vaccine effectiveness study conducted… read more.

Analyses published in NEJM of a third booster shot of the Comirnaty messenger RNA vaccine from Pfizer

Written by | 19 Sep 2021

Publication of two separate analyses in The New England Journal of Medicine comes before a meeting of FDA advisers to discuss Pfizer’s application for authorization of a third… read more.

NHS launches world first trial for for new Galleri test to detect cancer

Written by | 17 Sep 2021

The NHS will launch the world’s largest trial of a revolutionary new blood test that can detect more than 50 types of cancer before symptoms appear. The first… read more.

SOPHIA Phase III study of Margenza announces final OS data in HER2-positive breast cancer patients – MacroGenics

Written by | 15 Sep 2021

MacroGenics announced the final overall survival (OS) results of the SOPHIA Phase III study of Margenza (margetuximab-cmkb) in adult patients with metastatic HER2-positive breast cancer. The final OS… read more.

Horizon Therapeutics initiates randomized controlled clinical trial evaluating Tepezza for the treatment of chronic (inactive) thyroid eye disease

Written by | 14 Sep 2021

Horizon Therapeutics plc has announced that the first patient has been enrolled in a Phase IV clinical trial evaluating the efficacy and safety of Tepezza for the treatment… read more.

The Bristol-Myers Squibb-Pfizer Alliance welcomes the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis Patents

Written by | 11 Sep 2021

The Bristol-Myers Squibb-Pfizer Alliance issued the following statement: We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August… read more.

FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions

Written by | 10 Sep 2021

Based on a completed FDA review of a large randomized safety clinical trial, the FDA has concluded there is an increased risk of serious heart-related events such as… read more.

FDA approves Trudhesa nasal spray for the treatment of acute migraine – Impel Neuropharma

Written by | 9 Sep 2021

Impel NeuroPharma, Inc. announced that the FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in… read more.

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